‡In the COSENTYX 300-mg treatment arm, 81% and 84% of patients in ERASURE and FIXTURE, respectively, who achieved PASI 75 at Week 12 sustained their response at Week 52. In the COSENTYX 150-mg treatment arm, 72% and 82% of patients in ERASURE and FIXTURE, respectively, who achieved PASI 75 at Week 12 sustained their response at Week 52.1

PASI 90 response rates were maintained from Year 1 to Year 52,4*(as observed analysis)

SCULPTURE uncontrolled extension: Patients received COSENTYX 300 mg every 4 weeks. PASI 75 responders at Week 12 were eligible to enter the maintenance period (90% of patients in the 300-mg arm achieved PASI 75 at Week 12 [nonresponder imputation]). At Week 52, patients could continue in the extension regardless of PASI 75 response.2,3

All data presented are as observed-patients with missing data at a specific time point are not included in the analysis2,3

As with open-label extensions, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may raise the proportion of responders in the overall population

If your patients answer yes to 3 or more questions, this could be indicative of psoriatic arthritis16*

Have you ever had a swollen joint (or joints)?

Has a doctor ever told you that you have arthritis?

Do your fingernails or toenails have holes or pits?

Have you had pain in your heel?

Have you had a finger or toe that was completely swollen and painful for no apparent reason?

*Psoriasis Epidemiology Screening Tool (PEST) questionnaire.

Consider a PsO treatment proven effective in PsA

#1

for PsA patients in rheumatology starting or switching biologic agents in the US17†

†NBRx Share for PsO/PsA/AS in Rheumatology offices allocated using SHS PTD Factors where RA (Rheumatoid Arthritis) is carved out for TNFs. NBRx is New to Brand measure showing the volume of NPA Prescriptions associated with first-time use of a product. It reports prescriptions for patients who are starting therapy with a product for the first time within the previous 12 months.

In the pivotal trial FUTURE 2,

(P<0.0001 for both Rx groups vs placebo)§

COSENTYX 300 mg (n=100): 54%

COSENTYX 150 mg (n=100): 51%

Placebo (n=98): 15%

Also shown in FUTURE 2,

Uncontrolled exploratory analysis as observed from baseline to 3 years, open label phase of the study

§All patients received an initial once-weekly X5 weeks loading dose followed by doses every 4 weeks.1

||COSENTYX 150-mg arm includes 31 patients who were up-titrated to 300 mg starting at Week 128, at the investigator's discretion.18

#Modified Total Sharp Score (mTSS) measures radiographic progression in the hands and feet and is expressed as the sum of two components: erosion scores and joint space narrowing.8

**In FUTURE 5, separate radiographs of each hand/wrist and each foot were taken at baseline, Week 16, and Week 24. Bone erosion, joint space narrowing, and total radiographic scores were determined using a PsA-modified van der Heijde-Sharp scoring method that included the second through fifth distal interphalangeal joints of each hand.8

95% of patients regained their PASI 75 response after retreatment with Cosentyx 300mg11*

n=136 (300mg)

12 weeks after relapse and initiation of retreatment in treatment withdrawal group in ERASURE and FIXTURE Extension study*†

*In placebo patients who relapsed and were retreated with COSENTYX 300 mg. Retreatment results are for patients retreated with COSENTYX after relapsing on placebo in the extension study (multiple imputation analysis). Relapse defined as loss of >50% of maximum PASI improvement compared to baseline of the core study.11

†At Week 12, after relapse and retreatment, PASI 75 and PASI 90 were achieved by 82% and 50% of patients, respectively, in the COSENTYX 150-mg arm (n=123). Median time to relapse was 20 weeks for patients on placebo who were retreated with COSENTYX 150 mg.11

PsO safety profile through Week 121

Infections were reported in 28.7% of patients on COSENTYX (n=1382) vs 18.9% on placebo (n=694)*

Adverse reactions reported by >1% of patients with plaque psoriasis through Week 12 in pivotal trials1

Inflammatory bowel disease in patients with PsO1

There were no cases of inflammatory bowel disease in placebo patients (n=793). One case of exacerbation of Crohn's disease was reported from long-term noncontrolled portions of ongoing clinical trials in plaque PsO.1

aPatient years is calculated as a sum of individual subject durations in days divided by 365 for each interval; bDeath was due to MACE, which was not considered by the investigators to be related to study drug; patient had ≥2 pre-existing MACE risk factors; c1 case was an exacerbation of previously existing ulcerative colitis; d1 case of cholangiocarcinoma, 1 case of invasive ductal breast carcinoma; e1 case of breast cancer; a subject with multiple occurrences of the same AE in a one-year interval was counted only once, while a subject with multiple occurrences of the same AE in different year intervals was counted for each year.

‡Includes neutropenia adverse events reported by investigators in the SCULPTURE study: does not include lab reports of neutropenia.

Consistent safety over time and across indications

In PsO through Week 12 and through 5 years1,4In PsA through Week 16 and through 3 years1,19

Enhanced Specialty Pharmacy Network (ESPN)

A single point of contact for the HCP, from Rx receipt through dispense

Benefits:

Facilitates enrollment of eligible PA-denied patients into the Covered Until You're Covered Program†without the requirement for an SRF

Informs you of the patient's status if the prescription is transferred to a payer-mandated specialty pharmacy

Uninsured or underinsured patients will be connected to the Novartis Patient Assistance Program to see if they are eligible for financial assistance

A complete list of the Enhanced Specialty Pharmacy Network is available through your Novartis representative. Enhanced Specialty Pharmacy Network providers can directly enroll eligible patients into the Covered Until You're Covered Program without the need for a Service Request Form. Eligible patients using other network specialty pharmacy providers require a completed Service Request Form sent to COSENTYX Connect to access the program.

150+ Specialty Pharmacy Providers

Broad availability to get COSENTYX that is convenient for you

Benefits:

Choose from our broad network of pharmacies

Flexibility in prescribing

Access to the Covered Until You're Covered Program via COSENTYX Connect

Patients can also be prescribed COSENTYX via a Service Request Form referred directly to COSENTYX Connect, if preferred.

†Covered Until You're Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, Tricare, or any other federal or state program. Patients may be asked to re-verify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice. Program enrollment must occur by [12/31/18].

Broad coverage: available for more than

213 MILLION COVERED LIVES12

$0 CO-PAY

for commercially insured patients*

*Limitations apply. For those commercially insured and 18 years or older. Up to a $16,000 annual cap. Patient will be responsible for any co-pay once limit is reached in a calendar year. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients. Novartis reserves the right to rescind, revoke, or amend this program without notice. Enrollment expires 12/31/18.

STUDY DESIGNS

The ERASURE study was a multicenter, randomized, double-blind, placebo-controlled trial of 738 patients.1

All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy1

All patients were followed for up to 52 weeks1

Coprimary end points were the proportion of subjects who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the IGA mod 2011 at Week 121

Other evaluated outcomes included the proportion of subjects who achieved a reduction in PASI score of ≥90% (PASI 90) from baseline at Week 12, maintenance of efficacy (PASI 75 and IGA clear or almost clear) to Week 52 in patients who were responders at Week 12, and improvements in itching, pain, and scaling at Week 12 based on the Psoriasis Symptom Diary20

Initial dosing: once weekly for 5 weeks; maintenance: once every 4 weeks, Week 8 through 48.1

The FIXTURE study was a multicenter, randomized, double-blind, placebo-controlled trial of 1306 patients.1

All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy1

All patients were followed for up to 52 weeks1

Coprimary end points were the proportion of subjects who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the IGA mod 2011 at Week 121

Other evaluated outcomes included the proportion of subjects who achieved a reduction in PASI score of ≥90% (PASI 90) from baseline at Week 12, maintenance of efficacy (PASI 75 and IGA clear or almost clear) to Week 52 in patients who were responders at Week 12, and improvements in itching, pain, and scaling at Week 12 based on the Psoriasis Symptom Diary.21

Initial dosing: once weekly for 5 weeks; maintenance: once every 4 weeks, Week 8 through 48.1

SCULPTURE was a randomized, double-blind, multicenter trial assessing PASI response and maintenance of response in patients with moderate to severe plaque psoriasis on either an FI regimen (every 4 weeks) or on a retreatment at SoR regimen.3

All patients had a BSA ≥10%, PASI score ≥12, IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy

The primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 Results - Weeks 12 and 52

At Week 12, 90% of patients in the 300-mg arm achieved PASI 75, and at Week 52, 78% and 60% of patients who continued COSENTYX 300 mg every 4 weeks maintained PASI 75 and PASI 90, respectively

Patients received COSENTYX at Week 12 and then every 4 weeks from the start of relapse (≥20% loss of maximum PASI score improvement vs baseline and a loss of PASI 75 response) until they achieved PASI 75 again.

The SCALP study was a multicenter, double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe scalp psoriasis.6

All patients were adults with chronic scalp psoriasis with or without plaque psoriasis elsewhere on the body for at least 6 months prior to randomization, and had moderate to severe scalp psoriasis defined as:6

All patients were adults with plaque type psoriasis, including moderate to severe psoriasis for at least 6 months, with significant involvement of palms and soles as defined by a ppIGA score of ≥3 and at least 1 extra-palmoplantar plaque on the skin7

Patients were required to be candidates for systemic therapy7

The primary end point was the proportion of patients achieving ppIGA 0/1 response and a reduction of at least 2 points from baseline on the ppIGA scale at Week 167

Secondary end points included ppIGA and ppPASI responses to Week 167

Patients in the placebo arm who were not ppIGA responders (did not achieve a ppIGA 0/1 and at least a 2-point reduction from baseline) were randomized to receive either COSENTYX 300 mg or 150 mg starting at Week 16 visit (5 weekly doses, followed by every 4 weeks thereafter).7

Placebo patients who were not ppIGA 0/1 responders by Week 76 were rerandomized to receive either COSENTYX 300 mg or COSENTYX 150 mg starting at Week 80.7

FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received COSENTYX 150 mg, 300 mg, or placebo subcutaneously at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status.1,18

The primary end point was the percentage of patients with ACR20 response at Week 24. After 1 year, patients were unblinded and continued to receive the same active dose as open-label treatment and were assessed every 8 weeks through 2 years and every 12 weeks through 3 years. Starting Week 128, patients whose signs and symptoms were not fully controlled and might improve further with an increase in dose as judged by the investigator, were up-dosed from 150-mg dose to 300-mg dose. At Week 156, 31 patients from the 150-mg dose had been up-dosed to 300 mg1,18,22,23

75-mg dose included in study but not shown18

Study population was mixed: 2/3 of patients were anti-TNF-α naive and 1/3 were anti-TNF-α experienced1

44% of patients treated with COSENTYX were treated with concomitant methotrexate at baseline18

The primary end point was the percentage of patients with ACR20 response at Week 168

Secondary end points included change in mTSS score at Week 24 from baseline, ACR50 response at Week 16, proportion of patients with dactylitis and enthesitis changes from baseline, and overall safety and tolerability8

Study population was mixed: more than 2/3 of patients were anti-TNF-α naive and less than 1/3 were anti-TNF-α experienced8

The ERASURE and FIXTURE extension study is a multicenter, double-blind, randomized, uncontrolled, withdrawal study of COSENTYX in patients completing 52 weeks in the ERASURE and FIXTURE studies.11

Patients treated with COSENTYX 300 mg or 150 mg during the maintenance period in either the ERASURE or FIXTURE core studies and exhibited PASI 75 at Week 52 were eligible to be rerandomized 2:1 to continue the same COSENTYX dose or receive placebo (withdrawal from active treatment)11

Placebo patients who experienced relapse (defined as loss of >50% of maximum PASI improvement compared to baseline of the core study) at any visit were retreated with 5 weekly doses of COSENTYX 300 mg (n=136) or 150 mg (n=123), followed by 1 dose every 4 weeks11

Retreatment results are for patients retreated with COSENTYX after relapsing on placebo in the extension (multiple imputation analysis)11

Primary end point was loss of PASI 75 response from baseline (week 52) up to week 68. Other end points included PASI 50/75/90 and IGA mod 2011 0 or 1 response rates over time, proportion of patients who relapsed, and PASI 50/75/90 response rates over time in patients who were retreated with COSENTYX 300 mg or 150 mg after relapse on placebo11

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects.

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects. In placebo-controlled clinical trials in patients with moderate to severe plaque psoriasis, higher rates of common infections such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%), and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo- controlled trials in patients with psoriatic arthritis and ankylosing spondylitis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in patients treated with COSENTYX during clinical trials in plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory study in 59 patients with active Crohn's disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in patients treated with COSENTYX in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable cap of the COSENTYX Sensoready® pen and the COSENTYX prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Vaccinations

Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines.

Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects. In placebo-controlled clinical trials in patients with moderate to severe plaque psoriasis, higher rates of common infections such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%), and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo- controlled trials in patients with psoriatic arthritis and ankylosing spondylitis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in patients treated with COSENTYX during clinical trials in plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory study in 59 patients with active Crohn's disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in patients treated with COSENTYX in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable cap of the COSENTYX Sensoready® pen and the COSENTYX prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Vaccinations

Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines.

Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.